Gastric Outlet ObstructionMADNCT00487552
Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction
A study testing Cook Magnetic Anastomosis Device (MAD) with Stent in people with Gastric Outlet Obstruction, run by Cook Group Incorporated at 4 sites in 3 countries.
Trial summary
The purpose of this study is to determine if the Cook Magnetic Anastomosis Device can be used to safely and successfully create a patent gastrojejunal anastomosis in subjects requiring treatment of gastric outlet obstruction caused by malignancy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Outlet Obstruction
- What is being tested?
- Cook Magnetic Anastomosis Device (MAD) with Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jan 2008to Apr 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with unresectable malignancy with, or at risk of developing gastric outlet obstruction with GOOSS ≤ 2
- Karnofsky Performance Score ≥ 60
Who cannot join
- Patient is unable to understand and execute informed consent
- Age below 18 years
- Patients with any prior gastrointestinal surgery that significantly alters gastrojejunal anatomy
- Implanted cardiac pacemaker, defibrillator or ventricular assist device
- Requirement for chronic anticoagulation, or with uncorrectable coagulopathy
- Patients receiving chronic steroids or other drugs that may impair wound healing or formation of an intact anastomosis
- Simultaneously participating in another investigational drug or device
- Patients with suspicion of, or documented multiple small bowel strictures
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Netherlands2 sites
Amsterdam Academic Medical Center
Amsterdam
University Medical Center Utrecht
Utrecht
About this study
Official title: Endoscopic Gastroenteric Anastomosis Formed by Magnetic Compression and Stent Placement for Palliation of Malignant Gastric Outlet Obstruction
The purpose of this study is to determine if the Cook Magnetic Anastomosis Device can be used to safely and successfully create a patent gastrojejunal anastomosis in subjects requiring treatment of gastric outlet obstruction caused by malignancy.
Read the detailed description
Surgical treatments for malignant gastric outlet obstructions carry substantial risks and are associated with postoperative morbidity. External compression from advancing tumor or tissue growth through the stent can cause stenosis or re-obstruction. In these patients, the creation of a patent fistula that allows gastric emptying may significantly improve palliation. Minimally invasive techniques that carry no greater risks than enteral stenting may provide a viable palliative treatment. The primary objectives are safety, and successful creation of a gastro-jejunal anastomosis. Secondary objectives are successful resumption or improvement in the ability to tolerate PO feeding, rate of stent migration, and duration of stent and anastomosis patency.
- Conditions
- Gastric Outlet Obstruction
- Being tested
- Cook Magnetic Anastomosis Device (MAD) with Stent
- Keywords
- endoscopy, esophagogastroduodenoscopy, gastric outlet obstruction, gastro-jejunostomy, gastric malignancy, duodenal stent, Malignant Gastric Outlet Obstruction
- Medical subject headings
- Gastric Outlet Obstruction, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cook Magnetic Anastomosis Device (MAD) with StentDevice
Gastro-jejunal anastomosis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | palliative treatment of gastric outlet obstruction Receives: Device: Cook Magnetic Anastomosis Device (MAD) with Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate Associated With the Creation of a Gastro-jejunal Anastomosis Using the Cook Magnetic Anastomosis Device With Trans-anastomotic Deployment of a Gastro-jejunal or Duodenal Stent
Success is defined as placement of the gastric and jejunal magnets, creation of the anastomosis, and deployment of the gastro-jejunal stent.
Measured: Approximately 8-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionApr 2011
Why it stopped: Failure to achieve one of the primary endpoints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric Outlet ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MED Institute, Incorporated, Cook Endoscopy
- Responsible party
- Sponsor
- Investigators
- Paul Fockens, MD, PhD, Principal investigator, Amsterdam Academic Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487552
- Sponsor's protocol ID
- 06-014
- Other IDs
- 900000
- Acronym
- MAD
- Status last verified
- Jul 2017
- First submitted
- 15 Jun 2007
- Last updated
- 23 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Gastroenteric Anastomosis Formed by Magnetic Compression and Stent Placement for Palliation of Malignant Gastric Outlet Obstruction
- ClinicalTrials.gov ID
- NCT00487552
- Acronym / sponsor ID
- MAD / 06-014
- Conditions
- Gastric Outlet Obstruction
- Keywords
- endoscopy, esophagogastroduodenoscopy, gastric outlet obstruction, gastro-jejunostomy, gastric malignancy, duodenal stent, Malignant Gastric Outlet Obstruction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to achieve one of the primary endpoints.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- MED Institute, Incorporated, Cook Endoscopy
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 18 Jun 2007 (estimated)
- Results
- Posted 27 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the Cook Magnetic Anastomosis Device can be used to safely and successfully create a patent gastrojejunal anastomosis in subjects requiring treatment of gastric outlet obstruction caused by malignancy.
Detailed description
Surgical treatments for malignant gastric outlet obstructions carry substantial risks and are associated with postoperative morbidity. External compression from advancing tumor or tissue growth through the stent can cause stenosis or re-obstruction. In these patients, the creation of a patent fistula that allows gastric emptying may significantly improve palliation. Minimally invasive techniques that carry no greater risks than enteral stenting may provide a viable palliative treatment. The primary objectives are safety, and successful creation of a gastro-jejunal anastomosis. Secondary objectives are successful resumption or improvement in the ability to tolerate PO feeding, rate of stent migration, and duration of stent and anastomosis patency.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Cook Magnetic Anastomosis Device (MAD) with Stentpalliative treatment of gastric outlet obstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with unresectable malignancy with, or at risk of developing gastric outlet obstruction with GOOSS ≤ 2
- Karnofsky Performance Score ≥ 60
Key exclusion criteria (8 listed)
- Patient is unable to understand and execute informed consent
- Age below 18 years
- Patients with any prior gastrointestinal surgery that significantly alters gastrojejunal anatomy
- Implanted cardiac pacemaker, defibrillator or ventricular assist device
- Requirement for chronic anticoagulation, or with uncorrectable coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cook Magnetic Anastomosis Device (MAD) with StentGastro-jejunal anastomosis | Device | 1 |
Primary outcome
Success Rate Associated With the Creation of a Gastro-jejunal Anastomosis Using the Cook Magnetic Anastomosis Device With Trans-anastomotic Deployment of a Gastro-jejunal or Duodenal Stent
Time frame: Approximately 8-10 days
Success is defined as placement of the gastric and jejunal magnets, creation of the anastomosis, and deployment of the gastro-jejunal stent.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Fockens, MD, PhD principal investigator
Amsterdam Academic Medical Center
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cook Magnetic Anastomosis Device (MAD) with Stent in people with Gastric Outlet Obstruction, run by Cook Group Incorporated at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, Belgium, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate Associated With the Creation of a Gastro-jejunal Anastomosis Using the Cook Magnetic Anastomosis Device With Trans-anastomotic Deployment of a Gastro-jejunal or Duodenal Stent (time frame: Approximately 8-10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.